The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Nemolizumab, also known as Nemluvio, to help with the treatment of atopic dermatitis (eczema) in the UK.
Nemolizumab, which has been approved for adults and adolescents aged twelve and upwards with a bodyweight of at least 30kg, has also shown success with reducing symptoms of prurigo nodularis, a skin condition that causes itching and nodules.
Nemolizumab is a monoclonal antibody that blocks the binding of Il-31 to its receptor, IL-31RA, to prohibit the signalling to cells that produce itching and inflammation. It is administered as an injection with a recommended dosage of 30mg.
The MHRA’s decision to approve Nemolizumab was based on results following successful Phase III clinical trials where 56.3% of patients (aged 18 years and over) experienced a significant decrease in itchy skin.
Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said: ‘We’re assured that the appropriate regulatory standards for the approval of this medicine have been met’ and that ‘as with all products, we will keep its safety under close review’. This acts as a reminder of the importance of post-market surveillance and continuous monitoring of the safety and effectiveness of new market drugs.
The National Institute for Health and Care Excellence (NICE) is deciding whether to approve Nemolizumab for use by the National Health Service (NHS). Further guidance is expected to be published on 21 May 2025.
More information is available on the MHRA website.
